Description

The goal of this clinical research study is to learn if adding panitumumab to the combination of carboplatin and paclitaxel can help to control inflammatory breast cancer when given before other standard chemotherapy and surgery. The safety of these drug combinations will also be studied.

This is an investigational study. Panitumumab is FDA approved and commercially available for the treatment of EGFR-expressing metastatic colorectal cancer with disease progression. Paclitaxel, carboplatin, doxorubicin and cyclophosphamide are FDA approved and commercially available for the treatment of breast cancer. The addition of panitumumab to the combination of carboplatin and paclitaxel is investigational and currently being used for research purposes only.

Status

Accepting new patients

Primary Study Objective(s)

The primary objective of this study is to determine the pathologic complete response (pCR) rate in patients with primary triple-receptor negative inflammatory breast cancer (TN-IBC).

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who:

Have histological confirmation of breast carcinoma (required

Have IBC, confirmed according to international consensus criteria (required):

Have negative HER2 expression on IHC (defined as 0 or 1+) or FISH analysis (required) (If HER2 is 2+, negative HER2 expression must be confirmed by FISH (HER2/cep17 ration <2, and/or copy number less than 6). ER and PgR expression should be less than 10%.)

Are 18 years of age or older (required)

Have LVEF >=50% by multigated acquisition scan (MUGA) or echocardiogram before study randomization

If of childbearing potential (women who are postmenopausal for <1 year, not surgically sterilized, or not abstinent), have a negative urine pregnancy test, and agree to the consistent and correct use of one of the following acceptable methods of birth control: male partner who is sterile before the female subject's entry into the study and is the sole sexual partner for that female subject; intrauterine device, oral contraception, or barrier methods, including diaphragm or condom with a spermicide

Excluding patients who have:

Stage IV disease, if the metastatic sites are not amendable for local therapy (i.e. radiation and/or surgery), and are not candidates for breast surgery

History of radiotherapy for current breast cancer diagnosis

History of recent malignancies <5 years (except for cured non-melanomatous skin cancer or cured cervical carcinoma in situ)